Phase II Study of Chidamide with PD-L1 Inhibitor, Carboplatin, and Etoposide as First Treatment for Extensive-Stage Small-Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a combination treatment of Chidamide with a PD-L1 inhibitor, carboplatin, and etoposide as a first-line therapy for patients with extensive-stage small-cell lung cancer ES-SCLC. This Phase II, single-arm study aims to assess how this combination affects progression-free survival and other outcomes such as response rates and overall survival. The study is sponsored by China Medical University, China. Approximately 36 participants will receive an induction therapy consisting of Chidamide 15 mg orally on specific days in a 21-day cycle for 4 cycles combined with a PD-L1 inhibitor, carboplatin, and etoposide following their standard dosing guidelines. After induction, participants will continue with maintenance therapy using Chidamide 20 mg orally twice weekly and the PD-L1 inhibitor until disease progression, unacceptable side effects, withdrawal, or study end. Participants will be closely monitored during the study through assessments of tumor response using RECIST v1.1 criteria from baseline up to around 24 months. Safety and tolerability will also be tracked by recording any treatment-related side effects. The study includes regular evaluations and follow-ups to measure progression-free survival, objective response rate, disease control rate, duration of response, and overall survival over this period.

A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD-L1 Inhibitor, Carboplatin, and Etoposide as First-Line Treatment in Patients With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)